Unexpected events
Events may occur during a clinical trial which do not fall within the definition of a SUSAR and, thus, are not subject to the reporting requirements for SUSARs, even though they may be relevant in terms of subject safety.
For example, a major safety finding from a newly completed animal study (such as carcinogenicity). In accordance with article 53 of the CTR all unexpected events which affect the benefit-risk balance of the clinical trial, should be reported.
The notification of an unexpected event shall be made in CTIS without undue delay but no later than 15 days from the date the sponsor became aware of this event.
See also Question 7.24 of the Q&A CTR.